FDA and O&P
Which rules set forth by the U.S. Food & Drug Administration apply to O&P businesses? By Thomas F. Fise, JD
B
efore we begin, let’s conduct a quick test of your current knowledge about the U.S. Food & Drug Administration (FDA), and how it does and can impact the activities of O&P facilities that fall within the law. Take the following True/False quiz: 1. All O&P devices are Class I, and, therefore, good manufacturing practices (GMPs) do not apply to any manufacturer, distributor, or patient-care facility that might be inspected by FDA.
TRUE
FALSE
2. FDA is required to notify you in advance to clear a date for inspection.
TRUE
FALSE
3. Devices that have qualified for exemption from the GMP/quality system regulations (QSRs) of 21 CFR, Part 820, are the only O&P devices that are completely exempted from the unique device identifier (UDI) rules.
TRUE
FALSE
4. An O&P patient-care facility that does not operate central fabrication facilities for others is not required to register with FDA.
TRUE
FALSE
5. Any entity that serves as the initial U.S. distributor of imported medical devices can expect that FDA will hold it to the same responsibilities that would apply if it were the manufacturer of the device.
TRUE
FALSE
Now that you have completed the quiz, let’s discuss some important topics regarding how FDA regulations may affect O&P companies.
Good Manufacturing Practices O&P professionals may wonder, “Does my business have any responsibility to meet FDA requirements on manufacturers, such as GMPs?” This is an important question and determines how deeply your company should be focused on FDA matters. The answer should be—and used to be—an easy one. The current answer is somewhat more complicated due to some changes relevant to O&P businesses as well as changes regarding how aggressively FDA is seeking to assert its authority. Here are some guidelines. Generally, O&P suppliers, being those who actually make the components and raw materials that are used in devices furnished to patients in O&P care, are manufacturers, which must register with FDA, list their devices, meet GMPs for any devices they make to which those GMPs apply, and be subject to FDA reporting and recordkeeping guidelines. Distributors, which sell devices— from off-the-shelf (OTS) orthotics to components of custom-fabricated orthotics and prosthetics—are generally not considered manufacturers unless one or both of the following are true: 1. They are the initial U.S. distributors of medical devices that originate outside the United States (or perhaps private labelers); and/or
O&P News | March 2018
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